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 Formulary Chapter 16: Paediatrics - Full Chapter
Notes:

PLEASE NOTE: THIS CHAPTER IS STILL UNDER CONSTRUCTION

This chapter contains information from BCAP, Microguide and 3T's but a joint finalised version has yet to be agreed. Please use the information presented here in combination with the appropriate local guidelines.

Paediatric Drugs and the Traffic Light System

This guidance applies:

  • only where a drug does not already have a TLS classification
  • only for long-term use of a medicine where the patient would not otherwise visit the initiating clinician or unit at intervals of 60 days or less

Paediatric drugs are frequently used outside the makers Summary of Product Characteristics since many manufacturers fail to conduct the relevant trials needed to secure licensed use in paediatrics. Local guidance has made clear that the BNF for Children is the accepted reference.

 

Drug Indication 

In BNF-C for indication and dose range

In BNF-C but outside indications or dose range Not in BNF-C

Licensed drug within SPC indications

Amber No Shared Care Protocol (SCP) needed

Red

Off label use of drug   (as per BNF-C definition page 2)

Amber if SCP agreed

Red

Unlicensed drug

Amber if SCP agreed

Red

 RCPCH and NPPG joint position statement - 

https://www.rcpch.ac.uk/resources/using-standardised-strengths-unlicensed-liquid-medicines-children-joint-position

 Details...
16.07  Expand sub section  Status Epilepticus
Controlled Drug Midazolam Maleate Oromucosal
(Epistatus®)
View adult BNF View SPC online
Formulary
Amber with Shared Care
  • Epistatus® Oromucosal solution prefilled single syringe 10mg/1ml  (licensed in adolescents from 10 years to less than 18 years
  • Epistatus® Oromucosal solution 10mg/ml prefilled syringes: 2.5mg/0.25ml, 5mg/0.5ml, 7.5mg/0.75ml, (unlicensed).  Individually wrapped in a pack of 4.
  • Do not prescribe Oromucosal solution 10mg/ml multidose 5ml bottle. In primary care, all patients should use the pre-filled syringe format as this is what the specialist primary care nursing team can provide training on for carers/schools/nurseries/after-school clubs etc.
  • Prescribe by BRAND (NB Buccolam brand is a different salt, STRENGTH and volume) 
  • See Shared Care Guidelines: Use of Oromucosal Midazolam as an intervention for prolonged seizures and prevention od Status Epilepticus in children under 10 years of age

Red Swindon only - when used for sedation and pre-med in theatres

 
   
Sodium Valproate 
(Various formulations)
View adult BNF View SPC online
Formulary
Amber
  • Crushable tablets 100mg
  • E/C tablets 200mg, 500mg
  • M/R tablets 200mg, 300mg, 500mg 
  • M/R capsules 150mg, 300mg
  • LiquidSF 200mg/5ml

COVID-19 MHRA have issued guidance - Valproate Pregnancy Prevention Programme: temporary advice for management during coronavirus (COVID-19)

 
Link  Valproate medicines (Epilim„, Depakote„): contraindicated in women and girls of childbearing potential unless conditions of Pregnancy Prevention Programme are met
Link  Valproate medicines and serious harms in pregnancy: new Annual Risk Acknowledgement Form and clinical guidance from professional bodies to support compliance with the Pregnancy Prevention Programme
   
Sodium Valproate 
(Intravenous injection)
View adult BNF View SPC online
Formulary
Red
  • 400mg

COVID-19 MHRA have issued guidance - Valproate Pregnancy Prevention Programme: temporary advice for management during coronavirus (COVID-19)

 
Link  Valproate medicines (Epilim„, Depakote„): contraindicated in women and girls of childbearing potential unless conditions of Pregnancy Prevention Programme are met
Link  Valproate medicines and serious harms in pregnancy: new Annual Risk Acknowledgement Form and clinical guidance from professional bodies to support compliance with the Pregnancy Prevention Programme
   
 ....
Key
note Notes
Section Title Section Title (top level)
Section Title Section Title (sub level)
First Choice Item First Choice item
Non Formulary Item Non Formulary section
Restricted Drug
Restricted Drug
Unlicensed Drug
Unlicensed
Track Changes
Display tracking information
click to search medicines.org.uk
Link to adult BNF
click to search medicines.org.uk
Link to SPCs
SMC
Scottish Medicines Consortium
Cytotoxic Drug
Cytotoxic Drug
CD
Controlled Drug
High Cost Medicine
High Cost Medicine
Cancer Drugs Fund
Cancer Drugs Fund
NHSE
NHS England
Homecare
Homecare
CCG
CCG
Blueteq
High Cost Drug Approval System

Traffic Light Status Information

Status Description

Red

RED - Hospital only – to be prescribed by a specialist and supplied from secondary care ONLY throughout treatment.  

Amber

Amber medicines are considered suitable for GP prescribing following specialist initiation or recommendation.  

Amber with Shared Care

Shared Care - these medicines require specialist initiation and stabilisation. Ongoing division of responsibility for drug and disease monitoring between specialist and GP by a Shared Care Guideline (SCG). If no SCG in place status reverts to red.  

Green

These medicines are appropriate for initiation in both primary and secondary care. Prescribing is appropriate within licensed or local recommendations.  

Self

Suitable for patient to be directed to buy themselves  

Grey

Not currently used. We intend to include this TLS in future to highlight where a decision to use this medicine is under review.   

Black

Not currently used. We intend to include this TLS in future to highlight where a decision has been made by either or both the local or national NHS not to routinely commission this preparation for its licensed indications. Do not prescribe.  

Red Specialist Centre

Not currently used. We intend to include this TLS in future to highlight where this medicine and indication is ONLY available through a Specialist Centre according to a NICE Highly Specialised Technology or NHSE Specialised Commission Circular / Policy.  

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